Sapphire 3 CTO Study

Sapphire 3 - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Performance of the Sapphire 3 0.85-1.25 mm Coronary Dilatation Catheter in Predilatation of Chronic Total Occlusion (CTO) Lesions During Percutaneous Coronary Intervention.

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention.

One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Chronic Total Occlusion; Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Device: Sapphire 3 Coronary Dilatation Catheter

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debbie Morrell, MSME; Phone Number: 954-343-6467; Email: dmorrell@orbusneich.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Clinical Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.

4. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization with planned stent placement during this index procedure.

   Angiographic Inclusion Criteria

5. Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria.
6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
7. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success by visual assessment.
8. The Target lesion is intended for stent placement during this index procedure.

Clinical Exclusion Criteria:

1. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
2. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as CK-MB or troponin greater than 1X the upper limit of normal (ULN).
3. Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
4. Planned or actual target lesion treatment prior to the use of the Study Device with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
5. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
6. Cerebrovascular accident (CVA) within the past 6 months.
7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.

8. Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary).

   Angiographic Exclusion Criteria

9. More than two lesions requiring treatment.
10. Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis).
11. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
12. Target lesion with angiographic presence of probable or definite thrombus of TIMI thrombus grade 3 or 4.
13. By visual estimation, target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.25 mm in diameter.
14. Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel.
15. Target vessel with a patent bypass graft from prior coronary bypass surgery.

16. Previous stenting (drug-eluting or bare metal) in the target vessel unless all the following conditions are met:

    • It has been at least 9 months since the previous stenting.
    • That target lesion is at least 15 mm away from the previously placed stent. Total occlusions involving an in-stent segment are excluded.
    • The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.

17. Non-target lesion to be treated during the index procedure meets any of the following criteria:

    • Located within a bypass graft (venous or arterial)
    • Left main location
    • Chronic total occlusion (CTO)
    • Is moderately to severely calcified.
    • Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
    • Treatment not deemed a clinical angiographic success

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sapphire 3 Coronary Dilatation Catheter; Single arm with investigational Sapphire 3 Coronary Dilatation Catheters	Device: Sapphire 3 Coronary Dilatation Catheter; To pre-dilate Chronic Total Occlusion (CTO) lesions in coronary arteries during the subject's index procedure with Sapphire 3 0.85mm, 1.0mm, and 1.25mm diameter Coronary Dilatation Catheters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device Procedural Success	Device procedural success consisting of the following: Successful delivery, inflation, deflation and withdrawal of the study balloon and after the guidewire has successfully crossed the CTO lesion into the true lumen of the vessel; No evidence of vessel perforation or dissections (Grade C or higher) related to the study balloon; Final TIMI flow grade of II or III at the conclusion of the PCI procedure	24 hours post-procedure or hospital discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	In-hospital Major Adverse Cardiac Events (MACE) which is a hierarchical composite of: All death (cardiac and non-cardiac); Myocardial infarction (MI); Target Lesion Revascularization (TLR)	24 hours post-procedure or hospital discharge, whichever comes first
Number of Deaths (Cardiac and Non-Cardiac)	All death (cardiac and non-cardiac)	24 hours post-procedure or hospital discharge, whichever comes first
Number of Participants With Myocardial Infarctions (MI)	Myocardial Infarctions (MI)	24 hours post-procedure or hospital discharge, whichever comes first
Number of Participants With Target Lesion Revascularization (TLR)	Target Lesion Revascularization (TLR)	24 hours post-procedure or hospital discharge, whichever comes first
Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel	In-hospital stent thrombosis (ST) Within the Target Vessel	24 hours post-procedure or hospital discharge, whichever comes first
Number of Participants With Absence of Sapphire 3 Study Balloon Rupture	Absence of Sapphire 3 Study Balloon Rupture	Peri-procedural
Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA)	Improvement in Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Sapphire 3 as greater than MLD from baseline.	Peri-procedural
Number of Participants With Technical Success	Technical Success defined as Achievement of TIMI grade II or greater antegrade flow in all ≥2.5-mm distal branch(es) with <30% residual stenosis of the target CTO lesion at the completion of the procedure, (independently measured by the Angiographic Core Lab using QCA).	Peri-procedural
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)	Clinically Significant Arrhythmias (Requiring Intervention)	24 hours post-procedure or hospital discharge, whichever comes first

Collaborators and Investigators

• Sponsor: OrbusNeich
• Collaborators: Avania
• Investigators: Principal Investigator: David Kandzari, MD, Piedmont Heart Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Coronary Artery Disease; Chronic Total Occlusion; Arteriosclerosis; Heart Diseases; Myocardial Ischemia; Coronary Disease; Chronic Total Occlusion of Coronary Artery
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Ischemia; Arteriosclerosis
• Other Study ID Numbers: VP-0786

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes